Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease

Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease: Role of Angiogenic Factors, Hemostasis and Uterine Artery Doppler

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00695942

Acronym

AngioPred

Enrollment

200

Registered

2008-06-12

Start date

2008-06-30

Completion date

2012-05-31

Last updated

2012-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placental Vascular Pathologies, Venous Thromboembolism Diseases

Keywords

preeclampsia, eclampsia, retroplacental hematoma, vascular IUGR, IUFD, VTE

Brief summary

Venous thromboembolic (VTE) disease is the first cause of maternal mortality in the world. Some other pregnancy pathologies called Placental Vascular Pathologies (PVP) are linked to VTE by biological thrombophilia and are the principal cause of perinatal mortality. the identification of predictive factors of risk of occurrence or recurrence of two pathologies could enable us to propose an appropriate monitoring of patients at risk.

Detailed description

Main aim: To evaluate echographic, doppler and biological markers in a prospective manner as a potential predictive factor of risk of PVP and VTE.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 50 Years

Healthy volunteers

Inclusion criteria

* previous history of one or more PVC episodes (preeclampsia, HELLPs, retroplacental hematoma, vascular IUGR\<10th percentile, recurrence miscarriage \>2, unexplained IUFD or IUFD after abruption placentae, eclampsia. * Previous history of personal VTE * Diabete (treated with diet or insulin) * chronic hypertension * chronic renal pathology * lupus * obesity * Antihopholipids syndrome * early and late pregnancy (\<18 years, \>38 years) * family history of cardiovascular disease of VTE * known biological thrombophilia without any personal past history of PVC or VTE

Exclusion criteria

* Multiple pregnancy * past history of in utero fetal death due to congenital malformations, rhesus incompatibility or an infection * previous history of IUGR which etiology was a chromosomal, genic or infectious anomaly

Design outcomes

Primary

Measure	Time frame
sFlt1/plGF ratio	20, 24, 28, 32, 36 weeks

Secondary

Measure	Time frame
SFlt1/PlGF ratio as predictive threshold to develop a PVP and/or a VTE	20, 24, 28, 32, 36 SA
thrombin generation test (TGT) as potential predictive factor risck oj PVP and VTE	20, 24, 28, 32 and 36 weeks
sEng, rTFPI, D-Dimer, uCRP, PP13 as potential predictive factor of risk of PVP and or VTE	20, 24, 28, 32 and 36 weeks
echographic data as potential predictive factors of VTE and or PVP	22 and 32 weeks

Countries

France

Outcome results